This Government Contract opportunity from Department Of Energy was posted on April 24, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Sterilization Process Validation and Regulatory Support
Contract Overview
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The contract requires comprehensive validation documentation and support for sterilization processes, including Installation Qualification, Operational Qualification, and Performance Qualification, along with Factory Acceptance Testing and Site Acceptance Testing. It further demands detailed dose mapping activities and full adherence to medical device regulatory standards to ensure the safety, efficacy, and compliance of sterilization procedures. All deliverables must meet rigorous industry and federal requirements, with a focus on quality assurance and regulatory readiness. The work is to be performed in Richland, Washington, under a subcontract arrangement through the Department of Energy’s PNNL Contracts division. The opportunity was posted on April 24, 2026, with a firm submission deadline of June 1, 2026. The NAICS code 541690 indicates the scope involves other scientific and technical consulting services, underscoring the specialized nature of the validation and regulatory support required. Contractors must demonstrate proven expertise in medical device compliance and sterilization process engineering to successfully fulfill the terms of this agreement.
General Info
Agency
NAICS
Place of Performance
Richland, WA, 99352, USASet-Aside
Documents
This scope was carved out of 42426-RD.
The full solicitation package (3 documents), including the RFP, is on the prime solicitation, not on this scope.
Request for Information (RFI) - Mid‑energy electron beam (eBeam) systems
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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